Evergreen Therapeutics announced that its AI‑enabled small molecule drug candidate EG‑101, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I clinical trial. This study will evaluate safety and preliminary pharmacodynamic effects in humans for the treatment of preeclampsia.
There are currently no approved therapies for preeclampsia worldwide. As a focused indication within Evergreen’s pipeline, preeclampsia represents a significant unmet medical need. The global market for its treatment was valued at over $1 billion in 2022 and is projected to reach $2.14 billion by 2030.
“In the development of EG-101, we leveraged our AI platform to construct genomic disease models and gain deeper insights into the pathophysiology of preeclampsia,” commented Dr. Charles Lee, Chief Medical Officer of Evergreen Therapeutics. “Our platform’s capability to enhance R&D efficiency and success rates has been previously validated through the development of EG-501 and EG-301. Building on AI-driven insights, our team is considering a more targeted enrollment strategy, potentially including specific patient subtypes in the Phase I clinical trial design.”
Evergreen Therapeutics’ core pipelines assets also include EG-301 for dry age-related macular degeneration (Dry-AMD), which received FDA clearance to enter Phase II clinical development in February 2022, and EG-501 for cognitive impairment associated with neuropsychiatric systemic lupus erythematosus (NPSLE), currently undergoing Phase II clinical trials. The development of all these programs has been significantly supported by deep integration of the company’s proprietary AI platform throughout development lifecycle.